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The AGITG and CTC today announced that the INTEGRATE IIa study, a phase III trial evaluated regorafenib for the treatment of patients with advanced gastro-oesophageal cancer (AGOC), has met its primary endpoint of a statistically significant improvement in overall survival of about 30%. The phase III INTEGRATE IIa study evaluated the efficacy and safety of regorafenib in patients with AGOC, whose disease has progressed after a minimum of two lines of prior anti-cancer therapy for recurrent/metastatic disease. The safety and tolerability were generally consistent with the known profile of regorafenib. Detailed efficacy and safety analyses from this study were presented today at the 2023 ASCO Gastrointestinal Cancers Symposium (ASCO GI).
The AGITG is leading a study currently conducted by the CTC, a multinational phase III study called INTEGRATE IIb, which is further investigating the combination of regorafenib and nivolumab, compared to standard chemotherapy alone.
The INTEGRATE IIa study is an international, double blind, placebo-controlled trial with 2:1 (regorafenib:placebo) randomisation of patients with evaluable gastro-oesophageal adenocarcinoma in the third line setting or later line. To be enrolled in the study, patients must have failed or been found intolerant to a minimum of two lines of prior anti-cancer therapy, including a platinum agent and a fluoropyrimidine analogue.
The study randomised 251 patients from 40 recruiting sites across six countries worldwide, including North America and Asia. Patients were randomised to receive either regorafenib 160mg or placebo, with best supportive care provided to each arm.
GASTRIC CANCER PROFILE
Gastric cancer is currently the fifth most common cancer (5.6% of all new cases), and the fourth most common cause of cancer-related deaths worldwide (7.7% of all deaths).1, 2 For AGOC there remains a poor prognosis, with chemotherapy or biologic therapy in the refractory setting associated with a median overall survival of less than six months and real-world data in stage IV disease associated with a 2-year overall survival of less than 10%.3, 4
About the Australasian Gastro-Intestinal Trials Group
The Australasian Gastro-Intestinal Trials Group (AGITG) is Australia and New Zealand’s peak body for GI cancer research. It is the only not-for-profit organisation in the region dedicated to improving the health and quality of life of patients with GI cancer by developing and conducting impartial and collaborative multi-disciplinary research. More background information is available at www.gicancer.org.au.
About NHMRC Clinical Trials Centre
The NHMRC Clinical Trials Centre (CTC) is a flagship centre of excellence in clinical trials at the University of Sydney. CTC runs studies designed to improve global health outcomes by bringing together world leading experts in healthcare, clinical trials, and related research methods. More background information is available at www.ctc.usyd.edu.au.
AGITG: Erin Burgess (firstname.lastname@example.org, 0402 152 592)
CTC: Sarah Munro (email@example.com)
Clinical Lead: Professor Tim Price (firstname.lastname@example.org)